FREMONT, Calif. (PRWEB) October 25, 2017
California-based Myoscience, Inc. announced that the Campbell Clinic in Memphis, TN, has started enrolling patients in a clinical trial to study the effect of the iovera° system in managing pain in post-surgical knee patients. The ioveraº technology is a non-opioid and non-systemic treatment for blocking pain signals from peripheral nerves.
One hundred twenty patients are to be enrolled in this trial. Patients will be randomized 1:1. Patients in the study arm will receive iovera therapy in the index knee 3 – 7 days before total knee arthroplasty, while patients in the control arm will receive current standard of care (without the iovera therapy).
Dr. William M. Mihalko, M.D., who is the Principal Investigator in this trial, stated: "At Campbell Clinic, we carefully evaluate new technologies to solve challenging clinical issues, and to improve patient outcomes. I am very excited to begin enrolling patients in the iovera° study looking at reducing pain and narcotic use after total knee replacement. I look forward to seeing the data from this study, which I hope will confirm all our findings and experiences to date. We hope the iovera° technology will help us meet one of the significant needs today – reducing the reliance on opioid based pain medication after total knee replacement surgery."
Patients from six orthopedic surgeons’ practices at the Campbell Clinic will participate in this trial, which aims to show that the iovera° therapy can help in significantly reducing opioid consumption after total knee replacement independent of surgical practice.
Cary G. Vance, President and CEO of Myoscience added, “I am very excited to see that we are able to conduct this study at a renowned institution like the Campbell Clinic. Data from this study will demonstrate and confirm that the iovera° technology can be a solution to help address the opioid epidemic in our nation today.”
The iovera° treatment uses the body’s natural response to cold to treat peripheral nerves. A sensory nerve will stop sending pain signals immediately after receiving targeted cold therapy via the iovera° treatment. The effect on the nerve is transient, providing pain relief until the nerve regenerates and its sensory function is fully restored. This pain relief is achieved without the use of habit-forming drugs such as opioids.
For additional information, please visit http://www.iovera.com or email us directly at contact(at)myoscience(dot)com.
Silicon Valley, California-based Myoscience is a privately-held medical device company committed to making its platform technology, the iovera° system, the standard of care for the treatment of peripheral nerves. The iovera° treatment is powered by the Focused Cold Therapy® delivery system, a patented miniaturization of traditional cryotherapy. The ioveraº system is 510k cleared in the U.S. for the blocking of pain, the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days and general surgical use. For more information, please visit http://www.iovera.com.
ABOUT TOTAL KNEE ARTHROPLASTY
Total knee replacement is one option to relieve pain and to restore function to an arthritic knee. The most common reason for knee replacement is that other treatments (weight loss, exercise/physical therapy, medicines, and injections) have failed to relieve arthritis-associated knee pain.
The goal of knee replacement is to relieve pain, improve quality of life, and maintain or improve knee function. The procedure is performed on people of all ages, with the exception of children, whose bones are still growing. It is important to have significant pain and/or disability prior to considering this procedure. Because the replacement parts can break down over time, and healthcare providers generally recommend delaying knee replacement until it is absolutely necessary.
Approximately 700,000 knee replacement procedures are performed annually in the US. This number is projected to increase to 3.48 million procedures per year by 2030(1).
(1) Kurtz S, Ong K, Lau E, et al. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am 2007; 89:780.
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